Breast Cancer Clinical Trial
Official title:
A Multicenter, Randomized, Phase II Trial Evaluating the Efficacy of Eribulin Monotherapy and Eribulin Plus Endocrine Therapy in Locally-recurrent or Metastatic Breast Cancer Patients After Progression on Endocrine Therapy (REVERT)
Verified date | August 2021 |
Source | MedSIR |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Unresectable, ER-positive and/or PR-positive and HER2-negative locally-recurrent or metastatic breast cancer (mBC).
Status | Terminated |
Enrollment | 22 |
Est. completion date | March 31, 2021 |
Est. primary completion date | March 31, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - ER-positive and/or PR-positive breast cancer. - HER2-negative breast cancer. - Unresectable locally advanced or metastatic breast cancer. - Confirmed disease progression while in the last aromatase inhibition-containing regimen in the metastatic setting. - At least one taxane or anthracycline regimen in either the adjuvant or the neoadjuvant setting. - Patients with no prior line of chemotherapy in the metastatic setting. - At least 1 and up to 3 prior lines of endocrine therapy in the metastatic setting. - ECOG score 0 or 1. - Patients have adequate bone marrow and organ function. - Patients must have measurable disease (RECIST v.1.1). - Premenopausal with LHRH analogues for at least 28 days) and postmenopausal women. - Patients must agree to not breastfeed during the study and for 3 months after the last dose of study treatment. - Life expectancy greater or equal to 12 weeks. - Patients agree to collection of blood samples (liquid biopsy) and optional collection of metastatic tumour sample (biopsy) at the time of inclusion and progression (if appropriate). Exclusion Criteria: - Have received radiation therapy or limited-field palliative radiotherapy within two weeks prior to Cycle 1, Day 1, or patients who have not recovered from radiotherapy-related toxicities. - Have received prior chemotherapy for locally advanced or metastatic disease. - Have peripheral neuropathy grade 2 or greater. - QTc > 480 msec on basal assessments, history of congenital or personal history of long QT syndrome, Brugada syndrome, or Torsade de Pointes (TdP), or uncontrolled electrolyte disorders - Child-bearing potential women not using highly effective methods of contraception. - Known hypersensitivity to eribulin, endocrine therapy or its excipients. - Other malignancies within the previous two years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of cervix or breast. - Known uncontrolled metastases to the central nervous system (CNS) or any progressing CNS disease. - Have a serious concomitant systemic disorder incompatible with the study. - Major surgical procedure or significant traumatic injury within 28 days prior to randomization. - Have received any anti-cancer biology or investigational treatment within 30 days prior to randomization. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Quiron Dexeus | Barcelona | Please Select |
Spain | Institut Català d'Oncologia | Girona | |
Spain | Hospital de Jaén | Jaen | Jaén |
Spain | Complejo Asistencial Universitario de León | León | |
Spain | Hospital Ramón y Cajal | Madrid | |
Spain | Hospital Universitario La Paz, | Madrid | |
Spain | Hospital Son Llatzer | Palma De Mallorca | |
Spain | Hospital Universitario Dr Peset | Valencia | |
Spain | Hospital Miguel Servet | Zaragoza |
Lead Sponsor | Collaborator |
---|---|
MedSIR |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The overall response rate (ORR) | The overall response rate (ORR) in the eribulin + ET arms, defined as the proportion of patients with best overall response of confirmed complete response or partial response based on local investigator's assessment according to Response Evaluation Criteria In Solid Tumours (RECIST) criteria v. 1.11. | Baseline up to 27 months | |
Secondary | The progression-free survival (PFS) | The progression-free survival (PFS) for patients treated with endocrine therapy alone or in combination with eribulin is defined as the time from randomization until death by any cause or objective tumor progression based on local investigator's assessment according to Response Evaluation Criteria In Solid Tumours (RECIST) criteria v. 1.11. | Baseline up to 27 months | |
Secondary | PFS-2, in the eribulin and the eribulin + ET arms | The PFS-2, in the eribulin and the eribulin + ET arms, defined as the time from the randomization to the second disease progression or death, i.e., PFS after the next line of treatment, based on local investigator's assessment according to Response Evaluation Criteria In Solid Tumours (RECIST) criteria v. 1.11. | Baseline up to 27 months | |
Secondary | Overall response rate (ORR) in the eribulin arm | The overall response rate (ORR) in the eribulin arm, defined as the proportion of patients with best overall response of confirmed complete response or partial response based on local investigator's assessment according to Response Evaluation Criteria In Solid Tumours (RECIST) criteria v. 1.11. | Baseline up to 27 months | |
Secondary | The duration of response (DOR) in the eribulin and the eribulin + ET arms | The duration of response (DOR) in the eribulin and the eribulin + ET arms, defined as the time from the start of the treatment to disease progression based on local investigator's assessment according to Response Evaluation Criteria In Solid Tumours (RECIST) criteria v. 1.11. | Baseline up to 27 months | |
Secondary | The clinical benefit rate (CBR) in the eribulin and the eribulin + ET arms | The clinical benefit rate (CBR) in the eribulin and the eribulin + ET arms, defined as the proportion of patients with no disease progression after 6 months of therapy, based on local investigator's assessment according to Response Evaluation Criteria In Solid Tumours (RECIST) criteria v. 1.11. | Baseline up to 27 months | |
Secondary | The overall survival (OS) in the eribulin and the eribulin + ET arms | The overall survival (OS) in the eribulin and the eribulin + ET arms, defined as the length of time that patients remain alive from the start of treatment (OS will be collected at the end of the study). | Baseline up to 27 months | |
Secondary | Maximum Tumor shrinkage | Maximum Tumor shrinkage, defined as the percentage of tumor shrinkage from baseline (obtained from the sum of the largest diameters of the target lesions), based on local investigator's assessment according to RECIST criteria guidelines (version 1.1)1. | Baseline up to 27 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04681911 -
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
|
Phase 2 | |
Completed |
NCT04890327 -
Web-based Family History Tool
|
N/A | |
Terminated |
NCT04066790 -
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
|
Phase 2 | |
Completed |
NCT03591848 -
Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility
|
N/A | |
Recruiting |
NCT03954197 -
Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients
|
N/A | |
Terminated |
NCT02202746 -
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
|
Phase 2 | |
Active, not recruiting |
NCT01472094 -
The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
|
||
Recruiting |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
Recruiting |
NCT06049446 -
Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
|
||
Recruiting |
NCT05560334 -
A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations
|
Phase 2 | |
Active, not recruiting |
NCT05501769 -
ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer
|
Phase 1 | |
Recruiting |
NCT04631835 -
Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer
|
Phase 1 | |
Completed |
NCT04307407 -
Exercise in Breast Cancer Survivors
|
N/A | |
Recruiting |
NCT03544762 -
Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation
|
Phase 3 | |
Terminated |
NCT02482389 -
Study of Preoperative Boost Radiotherapy
|
N/A | |
Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
Completed |
NCT00226967 -
Stress, Diurnal Cortisol, and Breast Cancer Survival
|
||
Recruiting |
NCT06019325 -
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy
|
N/A | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 |